PURPOSE: These rules provide for the dispensing of Schedule V controlled substances, for the dispensing of Schedule II controlled substances in emergency situations and for the emergency distribution of a controlled substance.

1. (1) Emergency Dispensing of Schedule II Controlled Substances. In the case of a bona fide emergency situation, as defined by the Department of Health, a pharmacist may dispense a Schedule II controlled substance upon receiving oral authorization of a prescribing practitioner; provided, that—

   1. (A) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription;
   2. (B) The prescription immediately shall be reduced to writing by the pharmacist and shall contain all information, except for the prescribing practitioner’s signature;
   3. (C) If the prescribing practitioner is not known to the pharmacist, s/he must make reasonable effort to determine that the oral authorization came from a practitioner, by verifying his/her phone number against that listed in the directory and other good faith efforts to insure his/her identity; and
   4. (D) Within seventy-two (72) hours after authorizing an emergency oral prescription, the prescribing practitioner must cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The prescription shall have written on its face authorization for emergency dispensing. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the seventy-two (72)-hour period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Department of Health if the prescribing practitioner fails to deliver a written prescription to him/her; failure of the pharmacist to do so shall void the authority conferred by this section to dispense without a written prescription of a prescribing practitioner.

2. (2) Definition of Emergency Situation. For the purpose of authorizing an oral prescription of a controlled substance listed in Schedule II of the controlled substances law (sections 195.010–195.320, RSMo), the term emergency situation means those situations in which the prescribing practitioner determines that—

   1. (A) Immediate administration of a controlled substance is necessary for proper treatment of the intended ultimate user;
   2. (B) No appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II; and
   3. (C) It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance prior to the dispensing.

3. (3) Emergency Controlled Substance Distribution by a Pharmacy. An emergency means a situation where a quantity of a controlled substance must be dispensed by a pharmacy to a patient who does not have an alternative source for that substance reasonably available to him/her and the pharmacy cannot obtain that substance through its normal distribution channels within the time required to meet the immediate needs of the patient for that substance. In the event of an emergency, a pharmacy may distribute (without being registered as a distributor) a controlled substance in Schedule III, IV or V to a second pharmacy in order for that pharmacy to dispense the substance; provided, that—

   1. (A) The amount distributed does not exceed the amount required by the second pharmacy for his/her immediate dispensing;
   2. (B) The distribution is recorded as being dispensed by the first pharmacy and the second pharmacy records the substance as being received. Each pharmacy will retain a signed receipt of the distribution;
   3. (C) The second pharmacy is registered to dispense the controlled substance to be distributed to him/her; and
   4. (D) If the substance is a Schedule II controlled substance, an order form is required.

4. (4) Dispensing of Schedule V Substances, Requirement of Prescription.

   1. (A) A pharmacist directly may dispense a controlled substance listed in Schedule V pursuant to a prescription. A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription. If this authorization is given, the prescription may not be refilled. A pharmacist dispensing those substances pursuant to a prescription shall label the substance and file the prescription.
   2. (B) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule V in the course of his/her professional practice without a prescription.
   3. (C) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule V only pursuant to a written prescription signed by the prescribing individual practitioner or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required except for the signature of the prescribing individual practitioner) or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

5. (5) Dispensing Without Prescription. A controlled substance listed in Schedule V which is not a prescription drug and determined under the federal Food, Drug and Cosmetic Act may be dispensed by a pharmacist without a prescription to a purchaser at retail; provided, that—

   1. (A) Dispensing is made only by a pharmacist and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his/her professional and legal responsibilities, the actual cash transaction, credit transaction or delivery may be completed by a nonpharmacist);
   2. (B) Not more than two hundred forty cubic centimeters (240 cc) eight ounces (8 oz.) of any controlled substance containing opium, nor more than one hundred twenty cubic centimeters (120 cc) four ounces (4 oz.) of any other controlled substance nor more than forty-eight (48) dosage units of any controlled substance containing opium, nor more than twenty-four (24) dosage units of any other controlled substance may be dispensed at retail to the same purchaser in any given forty-eight (48)-hour period;
   3. (C) The purchaser is at least eighteen (18) years of age;
   4. (D) The pharmacist requires every purchaser of a Schedule V controlled substance not known to him/her to furnish suitable identification (including proof of age where appropriate);
   5. (E) A bound record book for dispensing of Schedule V controlled substances is maintained by the pharmacist. The book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with recordkeeping requirements); and
   6. (F) A prescription is not required for distribution or dispensing of the substance pursuant to any other federal, state or local law.

AUTHORITY: section 195.195, RSMo 1986.* This rule was previously filed as 13 CSR 50- 132.010. Original rule filed Jan. 31, 1972, effective April 1, 1972.

*Original authority: 195.195, RSMo 1957, amended 1971, 1989.